Locoregional Metastases in Malignant Melanoma Stages IIIB/CPhase 2NCT01341158
NAM-Trial: Multiferon in Malignant Melanoma
A Phase 2 study testing human interferon-α in people with Locoregional Metastases in Malignant Melanoma Stages IIIB/C, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The current clinical trial shall clarify the efficacy, safety and biologic effects of neoadjuvant treatment with natural interferon-α (Multiferon) in patients with locoregional metastases of melanoma in stage IIIB/C. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locoregional Metastases in Malignant Melanoma Stages IIIB/C
- What is being tested?
- human interferon-α
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven cutaneous melanoma
- Clinical stage IIIB or IIIC (AJCC 2010)
- ≥ 18 years of age
- Presence of at least two metastases, not more than 10 metastases, and completely resectable
- Measurable disease (at least one lesion that can be accurately measured in two perpendicular diameters, with both dimensions at least 10 mm x 10 mm for spiral CT and 5 mm x 5 mm for locoregional metastases assessed by ultrasound or digital photography)
- ECOG performance status of 0/1
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- Patients with previous adjuvant recombinant interferon-α treatment of any dose are eligible if (i) treatment was stopped at least 1 month before start of treatment and (ii) no progression occurred during interferon-α treatment.
- No childbearing potential or negative pregnancy test within 14 days before inclusion in women with child bearing potential Women with childbearing potential must be using an effective method of contraception (Pearl-Index < 1, e.g. oral contraceptives, other hormonal contraceptives [vaginal products, skin patches, or implanted or injectable products], or mechanical products such as an intrauterine device or barrier methods [diaphragm, spermicides]) throughout the study and for up to 3 months after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized.
- No men of fathering potential or men of fathering potential must be using an effective method of contraception to avoid conception throughout the study and for up to 3 months after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized.
- Signed and dated informed consent informed consent before the start of specific protocol procedures
Who cannot join
- Mucous membrane or ocular melanoma
- Any evidence of distant metastasis (e.g. whole body CT-scan including brain scan within 4 weeks before inclusion)
- Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months before inclusion, ventricular tachyarrhythmia requiring ongoing treatment, unstable angina pectoris).
- ALAT or ASAT > 2 x ULN
- Total bilirubin > 2 x ULN
- Creatinine > 2 x ULN
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- Evidence or history of depression. If this condition can not be ruled out, the patient should be transferred to a psychiatrist for consultation and further assessment before inclusion.
- Patients with seizure disorders requiring anticonvulsant therapy
- Any of the following abnormal baseline hematologic/laboratory values:
- Hb < 10g/dl WBC < 3.0x109 /l Platelets < 100x109 /l
- Presence of active autoimmune disease
- Concurrent systemic glucocorticoids or any other systemic immunosuppressive therapy
- Unwilling or unable to comply with the requirements of the protocol
- Known infection with HBV, HCV, HIV
- Pregnant or lactating women
- Unwillingness or inability to employ an effective barrier method of birth control throughout the study and for up to 3 months after end of treatment in female or male patients
- Known or suspected allergy to human interferon alpha or any ingredient of the IMP.
- Any thyroid dysfunctions not responsive to therapy
- Presence of chronic hepatitis with decompensated liver cirrhosis
- Immunosuppression in patients with transplantation
- Evidence or history of bleeding diathesis or coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Treatment of Locoregional Metastases in Malignant Melanoma (AJCC Stage IIIB/C) With Multiferon: a Phase IIa DeCOG Trial
The current clinical trial shall clarify the efficacy, safety and biologic effects of neoadjuvant treatment with natural interferon-α (Multiferon) in patients with locoregional metastases of melanoma in stage IIIB/C.
Read the detailed description
The study is an open label, multicenter phase IIa clinical trial which is designed as a pilot project in order to establish the efficacy and tolerability of Multiferon as a neoadjuvant treatment of locoregional metastases. Patients will be treated subsequently in cohorts characterized by different doses (3 - 9 - 18 MIU) to analyze dosage dependent effects.
- Being tested
- human interferon-α
- Keywords
- Malignatn Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human interferon-αDrug
Also called Multiferon
Neoadjuvant treatment: Multiferon is given as flat dosages (3 - 9 - 18 MIU) 5 days per week, subcutaneously for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Not described Receives: Drug: human interferon-α |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Overall response rate (clinical and radiological) after 4 weeks of treatment (CR + PR) according to immune-related response criteria (irRC)
Measured: after 4 weeks of treatment
Secondary outcomes (6)
Disease control rate
Disease control rate (CR + PR +SD) according to irRC
Measured: after 4 weeks of treatment
Rate of histopathological complete responses
Rate of histopathological complete responses
Measured: after 4 weeks of treatment
Tolerability
Assessment of numbers of adverse events
Measured: after 4 weeks of treatment
Differences in gene expression in metastatic tissue before/after treatment
Measured: after 4 weeks of treatment
Dose dependency of effects
Measured: after 4 weeks of treatment
Changes of serum markers and PBMC subsets before/after treatment (optional translational side studies)
Measured: after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locoregional Metastases in Malignant Melanoma Stages IIIB/CStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Weide, M.D., University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341158
- Sponsor's protocol ID
- 5021000
- Status last verified
- Nov 2014
- First submitted
- 19 Apr 2011
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment of Locoregional Metastases in Malignant Melanoma (AJCC Stage IIIB/C) With Multiferon: a Phase IIa DeCOG Trial
- ClinicalTrials.gov ID
- NCT01341158
- Acronym / sponsor ID
- 5021000
- Keywords
- Malignatn Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 25 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current clinical trial shall clarify the efficacy, safety and biologic effects of neoadjuvant treatment with natural interferon-α (Multiferon) in patients with locoregional metastases of melanoma in stage IIIB/C.
Detailed description
The study is an open label, multicenter phase IIa clinical trial which is designed as a pilot project in order to establish the efficacy and tolerability of Multiferon as a neoadjuvant treatment of locoregional metastases. Patients will be treated subsequently in cohorts characterized by different doses (3 - 9 - 18 MIU) to analyze dosage dependent effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: human interferon-α |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically proven cutaneous melanoma
- Clinical stage IIIB or IIIC (AJCC 2010)
- ≥ 18 years of age
- Presence of at least two metastases, not more than 10 metastases, and completely resectable
- Measurable disease (at least one lesion that can be accurately measured in two perpendicular diameters, with both dimensions at least 10 mm x 10 mm for spiral CT and 5 mm x 5 mm for locoregional metastases assessed by ultrasound or digital photography)
Key exclusion criteria (21 listed)
- Mucous membrane or ocular melanoma
- Any evidence of distant metastasis (e.g. whole body CT-scan including brain scan within 4 weeks before inclusion)
- Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months before inclusion, ventricular tachyarrhythmia requiring ongoing treatment, unstable angina pectoris).
- ALAT or ASAT > 2 x ULN
- Total bilirubin > 2 x ULN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human interferon-αAlso: MultiferonNeoadjuvant treatment: Multiferon is given as flat dosages (3 - 9 - 18 MIU) 5 days per week, subcutaneously for 4 weeks | Drug | Experimental arm |
Primary outcome
Overall response rate
Time frame: after 4 weeks of treatment
Overall response rate (clinical and radiological) after 4 weeks of treatment (CR + PR) according to immune-related response criteria (irRC)
6 secondary outcomes
Disease control rate
Time frame: after 4 weeks of treatment
Rate of histopathological complete responses
Time frame: after 4 weeks of treatment
Tolerability
Time frame: after 4 weeks of treatment
Differences in gene expression in metastatic tissue before/after treatment
Time frame: after 4 weeks of treatment
Dose dependency of effects
Time frame: after 4 weeks of treatment
Changes of serum markers and PBMC subsets before/after treatment (optional translational side studies)
Time frame: after 4 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing human interferon-α in people with Locoregional Metastases in Malignant Melanoma Stages IIIB/C, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: after 4 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.